A Phase Ia/ Ib Study of HS387 in Subjects With Advanced Solid Tumors
ConditionAdvanced Solid Cancers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang Hisun Pharmaceutical Co. Ltd.
About this trial
This is a Phase Ia/Ib, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and preliminary efficacy of HS387 in subjects with advanced solid tumors. It includes two parts: the dose escalation study (Phase Ia) and the dose expansion study (Phase Ib)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men or women ≥18 years old and ≤75 years old.
Subjects with advanced solid tumors who have failed or are intolerant to standard treatment, or have no standard therapy.
Survival expectation is ≥ 3 months.
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
Disqualifiers
Has received other investigational drugs or treatments not yet approved for marketing within 4 weeks prior to the first administration.
Has active infection.
Has meningeal metastases or symptomatic central nervous system (CNS) metastases.
Significant impairment of oral drug absorption.
Trial design
Design model
Single group
Treatments tested in this trial
HS387
DrugHS387 tablets will be given orally
Treatment groups
110 Participants
are divided into 1 treatment groupGroup A: HS387 groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants Reporting Adverse Events (AEs) or Serious Adverse Events (SAEs)
Adverse events (AE), serious adverse events (SAE), and severity of AE using the NCI-CTCAE version 5.0
Time frame
2 years2
Dose-limiting Toxicities Incidence Count Among Study Participant
DLT refers to Dose-Limiting Toxicity. It is defined as a side effect or adverse reaction of a drug or treatment that is severe enough to prevent an increase in dosage. Identifying DLT is crucial in clinical trials for determining the maximum tolerated dose (MTD) of a new drug.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov